Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
NCT ID:
NCT03664960
Description:
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
Frequency Threshold:
5
Time Frame:
Through study completion, up to 28 months
Study:
NCT03664960
Study Brief:
An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects in this arm received the placebo in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg. AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. | 0 | None | 2 | 21 | 20 | 21 | View |
| Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects in this arm received the active drug in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg. AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. | 0 | None | 9 | 37 | 32 | 37 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Spondylolisthesis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal hiernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neutrophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastroenteritis eosinophilic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Coronavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |